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Non-Surgical Intervention GSK study Prostatic neoplasms NCT00883909

- 11/26/17 - 1 form, 3 itemgroups, 12 items, 1 language
Itemgroups: Administrative data, Intervention non-surgical Prostate Cancer, Intervention non-surgical
Study ID: 103094 Clinical Study ID: ARI103094 Study Title: ARI103094-Follow-Up Study for REDUCE Study Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00883909 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Neoplasms, Prostate

Concomitant Medications GSK study Prostatic neoplasms NCT00883909

- 11/26/17 - 1 form, 3 itemgroups, 15 items, 1 language
Itemgroups: Administrative data, Concomitant Medications, Concomitant Medication
Study ID: 103094 Clinical Study ID: ARI103094 Study Title: ARI103094-Follow-Up Study for REDUCE Study Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00883909 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Neoplasms, Prostate

Hypofractionated Radiotherapy in Prostate Cancer NCT01368055 - Eligibility Criteria

- 3/15/21 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Hypofractionated Proton Radiation Therapy for Low and Intermediate Risk Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01368055

HistoScanning-based Brachytherapy in Prostate Cancer NCT01409876 - Eligibility Criteria

- 5/22/19 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Phase II trial looking at the feasibility of HistoScanning-based dose-painting image-guided interstitial brachytherapy in non-metastatic prostate cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01409876

SABR in High Risk Prostate Cancer (SATURN) NCT01953055 - Eligibility Criteria

- 5/22/19 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Phase II Study of Stereotactic Ablative Radiotherapy Including Regional Lymph Node Irradiation for Patients With High Risk Prostate Cancer (SATURN); ODM derived from: https://clinicaltrials.gov/show/NCT01953055

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 11 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 11

- 5/24/17 - 1 form, 22 itemgroups, 135 items, 1 language
Itemgroups: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 10 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 10

- 5/24/17 - 1 form, 22 itemgroups, 135 items, 1 language
Itemgroups: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 9 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 9

- 5/24/17 - 1 form, 22 itemgroups, 135 items, 1 language
Itemgroups: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 8 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 8

- 5/24/17 - 1 form, 22 itemgroups, 135 items, 1 language
Itemgroups: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 7 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 7

- 5/24/17 - 1 form, 22 itemgroups, 135 items, 1 language
Itemgroups: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 6 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 6

- 5/24/17 - 1 form, 22 itemgroups, 139 items, 1 language
Itemgroups: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 5 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 5

- 5/24/17 - 1 form, 22 itemgroups, 135 items, 1 language
Itemgroups: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

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